Swedish startup Natural Cycles, that offers an app-based product that it bills as a ‘digital contraceptive’, has been reported to Sweden’s Medical Products Agency (MPA) by a inner sanatorium after it available 37 neglected pregnancies among women who pronounced they had been regulating a app as their contraception method.

The women’s hospital of Södersjukhuset, in Stockholm, told us that it wants a MPA to examine how a app functions.

“We wish a Swedish Medicines Agency to accumulate information about side effects, such as neglected pregnancies, and demeanour during how a app works,” pronounced Lena Marions, a comparison alloy during a hospital and associate highbrow in obstetrics and gynaecology.

“The midwives of a termination accepting found that there were many women who were neglected profound and who settled that they used this app… Since Sep 2017, they remarkable how many women there were and afterwards reported a series to a Swedish Medicines Agency.”

“We always news to a Medical Products Agency if we understand that a medical product or drug is not operative as it is dictated to be done,” she combined in a emailed statement, also observant that the clinic has formerly reported other neglected pregnancies to a MPA — in that instance associated to women who had used an IUS (hormonal coil) as their preventive method.

A orator for a MPA reliable it is looking into a complaints, revelation us it has perceived “approximately 50 complaints” associated to neglected pregnancies in users of Natural Cycles’ device.

“The review is still in an early phase. The MPA has requested a manufacturer to contention commitment reports within dual weeks,” a orator added, suggesting it’s not nonetheless transparent either or not it will trigger a full investigation.

Responding to a complaint, Natural Cycles supposing us with a following statement:

No contraception is 100% effective, and neglected pregnancies is an hapless risk with any contraception. Natural Cycles has a Pearl Index of 7, that means it is 93% effective during customary use, that we also communicate. Our studies have regularly shown that a app provides a high turn of efficiency identical to other methods.

It also pronounced it has not nonetheless perceived any information from a clinic, observant it “cannot critique on specifics”, adding: “We are however in hold with a MPA and are responding to any particular reported case.

“At initial sight, a numbers mentioned in a media are not startling given a recognition of a app and in line with a efficiency rates. We have instituted an inner review with a clinical dialect in sequence to endorse this.

“As a user bottom increases, so will a volume of unintended pregnancies entrance from Natural Cycles app users, that is an unavoidable reality.”

Natural Cycles’ subscription product relies on an algorithmic routine to envision that days women are fruitful during their monthly cycle — with an in-app color-coded calendar informing users if they could have defenceless sex on a given day or not.

Women regulating a app are compulsory to magnitude and submit their physique heat daily regulating a fundamental thermometer. Natural Cycles relies on this and other particular information inputs to algorithmically calculate a luck of a user being fruitful on any day in her cycle.

As remarkable above, a association claims a product has an efficiency rate of 93 per cent with “typical use” — nonetheless this figure is formed on a self-selecting investigate of a possess users. As we have formerly reported, Natural Cycles has not carried out a randomized control hearing that would yield a aloft customary of explanation to behind adult a efficiency claims.

Nor has it carried out any analogous studies of a routine opposite other contraceptives such as a tablet or condom use. So it’s still not probable for users of a product to decider how effective Natural Cycles’ complement is vs some-more determined contraceptives methods — yet co-founder Dr Elina Berglund told us final tumble that it hopes to control such a investigate opposite condom use in future.

Last November, when Natural Cycles announced its $30M Series B, Berglund also reported a app carrying 500,000+ users opposite ~160 countries, revelation us a home marketplace of Sweden stays a largest market, followed by a UK and a US, where she suggested it was observant pointy growth.

Asked to mangle out active use in Sweden now a association declined to mention an accurate series — observant usually that it’s “one of a largest”.

Natural Cycles’ business gained a large informal boost in Feb 2017 when a product gained acceptance in a European Union as a preventive method.

It has also practical to a FDA for acceptance in a US, yet a comment routine for accreditation there is opposite and stays ongoing during this stage, with no guarantees it will be granted.

As good as being criticized for aloud selling efficiency claims that are usually formed on a self-selecting study, Natural Cycles’ product has captivated critique since it requires couples to remember to use an choice contraception routine if they have sex on days when a app informs them there’s a risk of pregnancy — with some women’s health experts warning of a relations complexity of this approach.

“It requires that a user follow a instructions really delicately and protects with condom when a lady is fertile. we consider we should be wakeful of that when regulating it,” remarkable Marions. “The app is improved matched for those women who might consider of removing pregnant, or comparison women who are reduction fertile.”

“There are several good contraceptives that yield good protection, such as spirals and p-rods. But there is no contraception that protects one hundred percent from pregnancy. It is always a lady who will select what suits her physique and lifestyle,” she added.

Responding to this critique, Natural Cycles pronounced it agrees a product is improved matched to comparison users, and serve noted: “You have to be over 18 to use Natural Cycles. The normal Natural Cycles user is 30 years and reduction than 1% are underneath 20.”

When we asked who Natural Cycles users were behind in November, Dr Berglund also told us: “Most women are between 25 and 35, they’re in a fast relationship, they’re mostly meditative about that they wish to have children in a few years and they don’t wish to take hormones anymore.”

It does also emphasizes a choice point, observant a idea is “to boost preventive choice so that all women find a suitable routine of contraception”.

“Today there is a large trend for women to pierce divided from hormonal contraception, and Natural Cycles can yield a useful choice for these women. We therefore expect, in fact, altogether to diminution a neglected pregnancy rates since we’re augmenting preventive choice, and see that many of a users are women who have not used any form of contraception before,” it added.